Apparatus, System, and Method for Treating Atypical Headaches

ABSTRACT

An apparatus, system, and method are disclosed for facilitating intranasal administration of a medication to a patient&#39;s sphenopalatine/pterygopalatine recess. The apparatus includes a catheter having a lumen disposed therethrough, the catheter comprising an insertion end and a manipulation end, the insertion end having an intrinsic curvature with respect to a longitudinal axis of the catheter such that the insertion end of the catheter lies in a first plane and the manipulation end lies in a second plane, wherein the catheter smoothly transitions between the first plane and the second plane, the intrinsic curvature conforming to a patients nasal anatomy such that the catheter may be inserted into a sphenopalatine/pterygopalatine recess. The apparatus also includes a straightening member configured to removably engage the catheter. The straightening member straightens the intrinsic curvature such that the first plane and the second plane are aligned when the catheter is engaged by the straightening member.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/094,323 entitled “Apparatus, system and method for treatingatypical headaches” and filed on Sep. 4, 2008 for Stephen Eldredge,which is incorporated herein by reference.

FIELD

This invention relates to parasympathetic nerve blockade and moreparticularly relates to blockade of sphenopalatine/pterygopalatineganglia.

BACKGROUND Description of the Related Art

Sympathetic pain is a type of nerve pain that arises due toabnormalities in the function of the sympathetic nervous system. Withsympathetic pain an abnormality in a group of nerves called a ganglioncause pain to an organ or body region. To treat sympathetic painphysicians can block a ganglion with the injection of medication into aspecific area of the body. To therapeutically treat acute pain aphysician injects a local anesthetic into the affected neuronalganglion. This type of treatment may be referred to as a nerve block.

The sphenopalatine/pterygopalatine ganglia is a neuronal structurelocated principally in the center of the head in the pterygopalatinefossa posterior to the middle turbinate. Thesphenopalatine/pterygopalatine ganglia comprises the largest cluster ofsympathetic neurons in the head outside of the brain. Thesphenopalatine/pterygopalatine ganglia interfaces and directs nerveimpulses to the majority of the head's autonomic or parasympatheticpathways. Therefore, any abnormality or injury to this structure maycause severe pain. A nerve block of the sphenopalatine/pterygopalatineganglia is effective in relief in a variety of pain conditions rangingfrom headache to lower back pain. Additionally, other disease processessuch as headache disorders and other neurological conditions can bearrested, or improved by local anesthetic blockade, and/or otherpharmacological augmentation or mechanical alteration of thesphenopalatine/pterygopalatine ganglia and surrounding structures.

Unfortunately, because of the anatomical position of thesphenopalatine/pterygopalatine ganglia, the structure is very difficultto block with a local anesthetic solution. The anatomical location ofthe sphenopalatine/pterygopalatine ganglia is dangerously close to manyvital and delicate mid brain structures. Although direct needleplacement can be employed under fluoroscopic guidance to administeranesthetic to the sphenopalatine/pterygopalatine ganglia, mostpractitioners will not attempt the procedure due to the technicaldifficulty and extreme dangers of an aberrant needle placement.

SUMMARY

From the foregoing discussion, it should be apparent that a need existsfor an apparatus, system, and method for treating parasympathetic nervepain in the sphenopalatine/pterygopalatine ganglia. Beneficially, suchan apparatus, system, and method would administer medication directly tothe sphenopalatine/pterygopalatine ganglia.

The present invention has been developed in response to the presentstate of the art, and in particular, in response to the problems andneeds in the art that have not yet been fully solved by currentlyavailable local anesthetic blockade methods, systems and apparatus foradministering medication to a patient's sphenopalatine/pterygopalatineganglia. Accordingly, the present invention has been developed toprovide an apparatus, system, and method for performing a nerve block ofthe sphenopalatine/pterygopalatine ganglia that overcome many or all ofthe above-discussed shortcomings in the art.

The apparatus, in one embodiment, includes a catheter, a straighteningmember, a spray orifice and a medication delivery port. In certainembodiments the catheter has a lumen disposed therethrough. The catheterincludes an insertion end and a manipulation end. The insertion end ofthe catheter has an intrinsic curvature with respect to a longitudinalaxis of the catheter such that the insertion end of the catheter lies ina first plane and the manipulation end lies in a second plane. Thecatheter smoothly transitions between the first plane and the secondplane such that the intrinsic curvature is rounded and conforms to apatient's nasal anatomy. In certain embodiments the intrinsic curvatureallows the catheter to be inserted into a sphenopalatine/pterygopalatinerecess with minimum discomfort to the patient.

In one embodiment the straightening member is configured to removablyengage the catheter. The straightening member straightens the intrinsiccurvature of the insertion end such that the first plane and the secondplane are aligned when the catheter is engaged by the straighteningmember. Thus, with the intrinsic curvature of the catheter straightened,the catheter can easily be inserted into a patients nasal cavity.

The spray orifice is located adjacent to the insertion end of thecatheter. The spray orifice is in fluid communication with the lumenwhich is in communication with the medication delivery port. Themedication delivery port is located adjacent to the manipulation end ofthe catheter and is configured to receive a medication and deliver themedication through the lumen to the spray orifice.

The apparatus, in one embodiment, also includes a second lumen. Thestraightening member in certain embodiments includes a stylus configuredto be received within the second lumen. In one embodiment the stylus iskeyed to fit within the second lumen in one predefined orientation. Insuch an embodiment the stylus may identify a direction of the intrinsiccurvature when the stylus is disposed within the second lumen. Thestylus may also include a finger tab for manipulating the catheter.

In another embodiment the straightening member may be a sleeveconfigured to receive the catheter. In such an embodiment the sleeve maybe configured to straighten the intrinsic curvature of the catheter whenthe catheter is received within the sleeve.

In one embodiment the apparatus may also include a rotational directionindicator that identifies a direction of the intrinsic curvature whenthe catheter is placed within the patient's nasal cavity. Thus, aphysician may be able to identify the rotational direction of the sprayorifice without being able to see the spray orifice or intrinsiccurvature. Similarly, in certain embodiments the apparatus may include adepth indicator located on the catheter to identifying a defined depth.In one embodiment the defined depth is a depth equaling a distancebetween an entrance to a patient's sphenopalatine/pterygopalatine recessand an external entrance to the patient's nostril. In certainembodiments the apparatus includes a second depth indicator located onthe catheter. The second depth indicator may identify a second defineddepth. The second defined depth may be a depth equaling a distancebetween a location at a posterior position within a patient'ssphenopalatine/pterygopalatine recess and an external entrance to thepatient's nostril. In one embodiment the depth indicators are moveableon the catheter so that a physician can adjust a position of the depthindicator according to a patient's nasal anatomy. In another embodimentthe depth indicators may be preposition to identify the typical distancebetween a patient's external opening of a nostril and the patient'ssphenopalatine/pterygopalatine recess. The typical distance between apatient's external opening of a nostril and the patient'ssphenopalatine/pterygopalatine recess may vary according to a patient'sgender or age.

A method of the present invention is also presented for treatingmigraines. The method in the disclosed embodiments substantiallyincludes the steps necessary to carry out the functions presented abovewith respect to the operation of the described apparatus. In oneembodiment, the method includes inserting a catheter and a straighteningmember into a nostril of a patient, advancing the catheter and thestraightening member past a middle sinus turbinate in the nostril of thepatient. The catheter includes an insertion end and a manipulation end.The insertion end has an intrinsic curvature with respect to alongitudinal axis of the catheter such that the insertion end of thecatheter lies in a first plane and the manipulation end lies in a secondplane. The catheter smoothly transitions between the first plane and thesecond plane with the intrinsic curvature conforming to a patient'snasal anatomy. This allows the catheter to easily be inserted into asphenopalatine/pterygopalatine recess. The straightening memberremovably engages the catheter and straightens the intrinsic curvatureof the insertion end such that the first plane and the second plane arealigned when the catheter is engaged by the straightening member.

The method also may include removing the straightening member from thecatheter such that the catheter bends in a direction towards asphenopalatine/pterygopalatine recess of the patient and advancing thecatheter into the sphenopalatine/pterygopalatine recess. In certainembodiments the method also includes dispensing a medication to asphenopalatine/pterygopalatine ganglia disposed within thesphenopalatine/pterygopalatine recess of the patient.

In a further embodiment, the method includes identifying a direction ofthe intrinsic curvature and aligning the intrinsic curvature of thecatheter with the patient's sphenopalatine/pterygopalatine recess. Inanother embodiment the method includes identifying a defined depth ofthe catheter. In one embodiment the defined depth is a depth equaling adistance between an entrance to a patient'ssphenopalatine/pterygopalatine recess and an external entrance to thepatient's nostril.

Reference throughout this specification to features, advantages, orsimilar language does not imply that all of the features and advantagesthat may be realized with the present invention should be or are in anysingle embodiment of the invention. Rather, language referring to thefeatures and advantages is understood to mean that a specific feature,advantage, or characteristic described in connection with an embodimentis included in at least one embodiment of the present invention. Thus,discussion of the features and advantages, and similar language,throughout this specification may, but do not necessarily, refer to thesame embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the advantages of the invention will be readilyunderstood, a more particular description of the invention brieflydescribed above will be rendered by reference to specific embodimentsthat are illustrated in the appended drawings. Understanding that thesedrawings depict only typical embodiments of the invention and are nottherefore to be considered to be limiting of its scope, the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings, in which:

FIG. 1 is a cutaway view illustrating one embodiment of the facialanatomy of a patient upon which the apparatus, system and method of thepresent invention may be employed;

FIG. 2 is a cutaway view illustrating a prior art method of treatingheadaches;

FIG. 3 is a cutaway view illustrating a prior art method of treatingheadaches;

FIG. 4 is a side view illustrating one embodiment of a sphenocathapparatus for treating headaches in accordance with the presentinvention;

FIG. 5A is a side view illustrating one embodiment of a sphenocathapparatus with a stylus inserted into a lumen to straighten thesphenocath in accordance with the present invention;

FIG. 5B is a side view illustrating one embodiment of a sphenocath witha stylus partially removed from the lumen such that the sphenocathcurves according to an intrinsic curvature in accordance with thepresent invention;

FIG. 5C is a side view illustrating one embodiment of a sphenocathapparatus with a catheter having an intrinsic curvature received withina sleeve to straighten the intrinsic curvature in accordance with thepresent invention;

FIG. 5D is a side view illustrating one embodiment of a sphenocath witha catheter having an intrinsic curvature partially removed from a sleevesuch that the intrinsic curvature curves in accordance with the presentinvention;

FIG. 6A is a cutaway view illustrating one embodiment of a catheter witha keyed lumen in accordance with the present invention;

FIG. 6B is a cutaway view illustrating one embodiment of a catheter withthree lumens in accordance with the present invention;

FIG. 6C is a cutaway view illustrating one embodiment of a catheter withfour lumens in accordance with the present invention;

FIG. 7 is a cutaway view illustrating one embodiment of a sphenocathinserted within the nasal cavity of a patient in accordance with thepresent invention;

FIG. 8 is a cutaway view illustrating one embodiment of a sphenocathadvanced into the sphenopalatine/pterygopalatine recess of a patient inaccordance with the present invention; and

FIG. 9 is a side view illustrating one embodiment of a sphenocathapparatus for treating headaches in accordance with the presentinvention;

FIG. 10 is a schematic block diagram illustrating one embodiment of amethod for treating headaches in accordance with the present invention.

DETAILED DESCRIPTION

Reference throughout this specification to “one embodiment,” “anembodiment,” or similar language means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of the present invention. Thus,appearances of the phrases “in one embodiment,” “in an embodiment,” andsimilar language throughout this specification may, but do notnecessarily, all refer to the same embodiment.

Furthermore, the described features, structures, or characteristics ofthe invention may be combined in any suitable manner in one or moreembodiments. In the following description, numerous specific details areprovided to provide a thorough understanding of embodiments of theinvention. One skilled in the relevant art will recognize, however, thatthe invention may be practiced without one or more of the specificdetails, or with other methods, components, materials, and so forth. Inother instances, well-known structures, materials, or operations are notshown or described in detail to avoid obscuring aspects of theinvention.

The schematic flow chart diagrams included herein are generally setforth as logical flow chart diagrams. As such, the depicted order andlabeled steps are indicative of one embodiment of the presented method.Other steps and methods may be conceived that are equivalent infunction, logic, or effect to one or more steps, or portions thereof, ofthe illustrated method. Additionally, the format and symbols employedare provided to explain the logical steps of the method and areunderstood not to limit the scope of the method. Although various arrowtypes and line types may be employed in the flow chart diagrams, theyare understood not to limit the scope of the corresponding method.Indeed, some arrows or other connectors may be used to indicate only thelogical flow of the method. For instance, an arrow may indicate awaiting or monitoring period of unspecified duration between enumeratedsteps of the depicted method. Additionally, the order in which aparticular method occurs may or may not strictly adhere to the order ofthe corresponding steps shown.

FIG. 1 is an illustration of the environment in which the presentinvention may be practiced. In particular, FIG. 1 depicts a cutaway viewof the anatomical features of a typical human nasal cavity. One skilledin the art will recognize that certain anatomical features andstructures of the human nasal cavity have been omitted to avoidobscuring the structures relevant to the practice of the currentinvention. To help orient the reader, the mouth 106 is illustrated withteeth 108 and tongue 110. The anatomical structures relevant to thepractice of the current invention include the palate 100 which separatesthe oral cavity 102 from the nasal cavity 104, the inferior sinusturbinate 112, the middle sinus turbinate 114 and the superior sinusturbinate 116 as well as the nasal bone 122. The middle sinus turbinate114 and superior sinus turbinate 116 define thesphenopalatine/pterygopalatine recess 118. Deep within thesphenopalatine/pterygopalatine recess 118 at the posterior 124 of thesphenopalatine/pterygopalatine recess 118 lies thesphenopalatine/pterygopalatine ganglia 120.

One skilled in the art will recognize that the medical community is notuniform in the terminology with regard to the sphenopalatine orpterygopalatine ganglia. Certain practitioners use sphenopalatine whileothers use pterygopalatine. Therefore, the present description willrefer to the ganglia labeled 120 as the sphenopalatine/pterygopalatineganglia 120. Similarly, the recess labeled 118 will be referred to asthe sphenopalatine/pterygopalatine recess 118. However, this terminologyis in no way limiting on the structure for which the present inventionis intended. Where practitioners or scientist differentiate between thesphenopalatine ganglia or the pterygopalatine ganglia, the presentdisclosure will be understood to apply to either structure.

Sympathetic pain is a type of nerve pain that arises due toabnormalities in the function of the sympathetic nervous system. Themajority of the “treatment resistant” headache population in the worldsuffers from what is now properly identified as “Sympathetic MediatedCephalgia” a particular type of sympathetic pain. With sympathetic painan abnormality in a group of nerves called a ganglion cause pain to anorgan or body region. To treat sympathetic pain physicians can block aganglion with the injection of medication into a specific area of thebody. To therapeutically treat acute pain a physician injects a localanesthetic into the affected neuronal ganglion. This type of treatmentmay be referred to as a nerve block.

The sphenopalatine/pterygopalatine ganglia 120 is a neuronal structurelocated principally in the center of the head in the pterygopalatinefossa posterior to the middle turbinate 114. Thesphenopalatine/pterygopalatine ganglia 120 comprises the largest clusterof sympathetic neurons in the head outside of the brain. Thesphenopalatine/pterygopalatine ganglia 120 interfaces and directs nerveimpulses to the majority of the head's autonomic or parasympatheticpathways. Therefore, any abnormality or injury to this structure maycause severe pain. A nerve block of the sphenopalatine/pterygopalatineganglia 120 is effective in relief in a variety of pain conditionsranging from headache to lower back pain. Additionally, other diseaseprocesses such as headache disorders and other neurological conditionscan be arrested, or improved by local anesthetic blockade, and/or otherpharmacological augmentation or mechanical alteration of thesphenopalatine/pterygopalatine ganglia 120 and surrounding structures.

Unfortunately, because of the anatomical position of thesphenopalatine/pterygopalatine ganglia 120, the structure is verydifficult to block with a local anesthetic solution. The anatomicallocation of the sphenopalatine/pterygopalatine ganglia 120 isdangerously close to many vital and delicate mid brain structures.Although direct needle placement can be employed under fluoroscopicguidance to administer anesthetic to the sphenopalatine/pterygopalatineganglia 120, most practitioners will not attempt the procedure due tothe technical difficulty and extreme dangers of an aberrant needleplacement.

As shown in the prior art illustration depicted in FIG. 2, thesphenopalatine/pterygopalatine ganglia 120 lies deep within thesphenopalatine/pterygopalatine recess 118. Conventional methodsundertaken by pain specialists, neurologists, and neurosurgeons, includethe use of an eight inch cotton-tipped applicator 200 saturated with alocal anesthetic. Because a cotton-tipped applicator 200 is used, theprocedure is referred to as the “Q-tip” procedure. The cotton-tippedapplicator 200 is soaked in a vial of concentrated local anestheticsolution. In certain embodiments the anesthetic solution is lidocaine,cocaine, etidocaine or prilocaine, or other non-specified localanesthetic agents. The cotton-tipped applicator 200 is then advancedinto the nostril 202 and through the nasal cavity 104. To reach thesphenopalatine/pterygopalatine ganglia 120 in thesphenopalatine/pterygopalatine recess 118, the cotton-tipped applicator200 must be advanced into the nasal cavity 104 past the middle sinusturbinate 114 and into the sphenopalatine/pterygopalatine recess 118.

FIG. 3 illustrates the tortuous path the cotton-tipped applicator 200 ofthe prior art must traverse to reach the sphenopalatine/pterygopalatinerecess 118. To perform the procedure the patient is placed in a supineposition. The cotton-tipped applicator 200 is soaked in a vial ofconcentrated local anesthetic solution. The physician then inserts thecotton-tipped applicator 200 into the patients nostril 202 and throughthe nasal cavity 104. Advancing the straight, rigid cotton-tippedapplicator 200 into the sphenopalatine/pterygopalatine recess 118 can bedifficult and painful for the patient as the cotton-tipped applicator200 must be inserted almost parallel to the patient's face to clear theanterior ridge 302 of the middle sinus turbinate 114. The cotton-tippedapplicator 200 must then make an almost 90° bend to avoid the inferiorsurface 304 of the nasal bone 122 and access thesphenopalatine/pterygopalatine recess 118. The cotton-tipped applicator200 is left in the patient's sphenopalatine/pterygopalatine recess 118for approximately 20 minutes to allow diffusion of the local anestheticthrough the sinus mucosa to depolarize thesphenopalatine/pterygopalatine ganglia 120 to block nerve transmission.

The use of a straight and rigid cotton-tipped applicator 200 that mustmake some fairly tortuous directional changes around some verysensitive, richly vascular, friable, highly innervated structurescomplicates the procedure to the point that many practitioners will notattempt it. Known complications include extreme patient discomfort,nosebleeds and the complications associated with nosebleeds includingvenous-irritating nuisances, arterial hemorrhaging, aspiration,hematochezia or even death. Other complications include local anesthetictoxicity, seizure, iatrogenic foreign bodies such as a brokencotton-tipped applicator 200, sinus mucosal tears and infection.

Anesthetic blockade of any neuronal structure requires direct physicalinteraction between the anesthetic solution and the targeted tissue.Therefore, to work, the cotton-tipped applicator 200 must deliver theanesthetic solution directly to the sphenopalatine/pterygopalatineganglion 120. The correct placement of the cotton-tipped applicator 200is technically challenging and many practitioners simply miss thedesired structure, the sphenopalatine/pterygopalatine ganglion 120 whenattempting to perform the procedure. To help make the complicated bendrequired to reach the sphenopalatine/pterygopalatine recess 118 manypractitioners will soak the top 2 inches of the cotton-tipped applicator200 and manipulate the stem to render it flexible so that the patient isless agitated and bleeding risks are lessened. Even with a flexiblecotton-tipped applicator 200 the procedure is difficult. Common failureplacements include the inferior surface 304 of the nasal bone 122 andthe anterior ridge 302 of the middle sinus turbinate 114. When thecotton-tipped applicator 200 is misplaced, a “wring-out” effect mayoccur wherein the anesthetic is wrung out of the cotton-tippedapplicator before it is delivered to the sphenopalatine/pterygopalatineganglion 120 resulting in an ineffective procedure. Further, asdiscussed above, the rich vascular and neuronal structure of the nasalcavity 104 makes any misplacement of the cotton-tipped applicator 200both dangerous and painful.

FIG. 4 illustrates a sphenocath 400 including a catheter 402 having aninsertion end 405 and a manipulation end 407. In certain embodiments thecatheter 402 includes multiple lumens 401 and 403. The catheter 402 hasan intrinsic curvature 404, a spray orifice 406, depth indicators 408, astraightening member 409 such as stylus 410 with a pull tab 412, amedication delivery port 414, a syringe 416, a rotational directionindicator 418 and a rotation tab 420.

In certain embodiments the sphenocath 400 comprises a soft sialasticdouble lumen catheter 402 which is about 24 cm long. One of skill in theart will recognize that the length of the catheter 402 may be variedaccording to the anatomy of the patient. One of the lumens 401 or 403 isconfigured to deliver an anesthetic or medication to thesphenopalatine/pterygopalatine recess 118. In certain embodiments theother lumen 401 or 403 is closed distally approximately 1.5 cm from spayorifice 406. For example, in certain embodiments lumen 401 comprises ahousing for stylus 410 and is closed at its distal end near the sprayorifice 406. The stylus 410 is slideably received within the lumen 401and may be removed from within the lumen 401 by pulling on the pull tab410.

As discussed in further detail below with reference to FIGS. 7 and 8,the sphenocath 400 is inserted into the nasal cavity 104 of a patientlying in a supine position. Depth indicators 408 identify when thesphenocath 400 has been inserted into a patients nasal cavity 104 at adepth sufficient to pass the middle sinus turbinate 114. In certainembodiments additional depth indicators (not shown) may indicate a depthsufficient to identify when the tip of the sphenocath 400 is within thesphenopalatine/pterygopalatine recess 118. One skilled in the art willappreciate that depth indicators 408 may vary depending on anatomicalvariables of the patient such as age and/or gender. The depth indicators408 may comprise a visual cue such as a line or other such indicator orthe depth indicators 408 may comprise a physical structure configured toarrest further insertion of the sphenocath 400. In certain embodimentsthe sphenocath 400 may be individually sized to fit only one size of apatient. Thus, the sphenocath 400, in certain embodiments, may comprisea large, medium or small size to be used with patients with large,medium or small anatomies. In another embodiment the depth indicators408 are adjustable such that the depth indicators 408 can be slid alongthe sphenocath 400 to a position which indicates a depth sufficient toidentify when the tip of the sphenocath 400 is within thesphenopalatine/pterygopalatine recess 118 of a particular patient.

The intrinsic curvature 404 of the catheter 402 causes the catheter 402to bend such that the insertion end 405 of the catheter 402 lies in afirst plane as indicated by line 411 while the manipulation end 407 ofthe catheter 402 lies in a second plane as indicated by line 413. Thecatheter 402 smoothly transitions between the first plane 411 and thesecond plane 413 such that the intrinsic curvature 404 conforms to apatient's nasal anatomy. The intrinsic curvature 404 allows the catheter402 to be inserted into a patient's sphenopalatine/pterygopalatinerecess 118 to direct a medication to the patient'ssphenopalatine/pterygopalatine ganglia 120.

Rotational direction indicator 418 identifies the rotationalconfiguration of the sphenocath 400. Because the end of the sphenocath400 has an intrinsic curvature 404, it is beneficial for the physicianto know which direction the curvature is pointing to manipulate thesphenocath 400 into the sphenopalatine/pterygopalatine recess 118. Incertain embodiments the rotational direction indicator 418 is configuredto signal the physician that the intrinsic curvature 404 and thus thespray orifice 406 is pointing in a downward angle when the rotationaldirection indicator 418 is pointing up. While the embodiment illustratedin FIG. 4 shows the rotational direction indicator 418 as a separatestructure, one skilled in the art will recognize that the rotationaldirection may simply be a line on top of the sphenocath indicating whichdirection the spray orifice 406 is pointing. In one embodiment, such asthe embodiment shown in FIG. 4, the rotational direction indicator 418may also comprise a rotation tab 420 to assist the physician inmanipulating the sphenocath 400 into the sphenopalatine/pterygopalatinerecess 118 by providing the physician a leverage point to rotate thesphenocath 400 and align the spray orifice with thesphenopalatine/pterygopalatine recess 118 orsphenopalatine/pterygopalatine ganglia 120.

Once the sphenocath 400 is manipulated into thesphenopalatine/pterygopalatine recess 118 the syringe 416 injects anantisthetic or medication into the medication delivery port 414 andthrough one of the lumens 401 or 403. The spray orifice 406 is in fluidcommunication with the lumen (401 or 403) that receives the medication,thus, as the physician injects or dispenses the medication intomedication delivery port, the medication travels through the lumen (401or 403), through the spray orifice 406, and into thesphenopalatine/pterygopalatine recess 118. One skilled in the art willrecognize that any metered medicinal or anesthetic delivery means may besubstituted for the syringe 416 without departing from the scope of thepresent invention.

The spray orifice 406 may be configured to deliver a stream ofmedication or anesthetic. In one embodiment the spray orifice 406 may beconfigured to disperse the medication or anesthetic such that the areasurrounding the sphenopalatine/pterygopalatine ganglia 120 is completelysaturated with anesthetic or medication. In certain embodiments thespray orifice 406 may be configured to administer the medication oranesthetic in a controlled fine mist. Further, one of skill in the artwill recognize that in certain embodiments the spray orifice 606 may beadjustable such that the physician may dispense the medication in abroader or narrower pattern as dictated by the procedure and thepatient's nasal anatomy.

FIG. 5A illustrates one embodiment of the catheter 402 portion of thesphenocath 400 with a rigid member 501 inserted into one of the lumens401 or 403. The rigid member 501 in the embodiments illustrated in FIGS.5A and 5B is a stylus 410 inserted into lumen 401 such that thesphenocath 400 is forced straight by the stylus 410. The stylus 410comprises a rod, wire or other rigid device having sufficient strengthto straighten the intrinsic curve 404 of the catheter 402. With thesphenocath 410 straightened the catheter 402 can be inserted into thenasal cavity 104 until it reaches a point past the anterior ridge 302 ofthe middle sinus turbinate 114.

FIG. 5B illustrates an embodiment of the catheter 402 portion of thesphenocath 400 with the rigid member 501, in this case the stylus 410,partially removed from lumen 401. As the stylus 410 is removed fromlumen 401, the catheter 402 bends due to the intrinsic curvature 404 ofthe catheter 402. Thus, once the sphenocath 400 has been inserted deepenough into the patient's nasal cavity 104 such that the tip has passedthe middle sinus turbinate 114, the stylus 410 is withdrawn from lumen401 to allow the catheter to bend at the intrinsic curvature 404. Thesphenocath 400 may then be inserted all the way into thesphenopalatine/pterygopalatine recess 118 to deliver the anesthetic ormedication to the sphenopalatine/pterygopalatine ganglia 120 orsurrounding anatomical structure. In certain embodiments the radius ofthe intrinsic curvature 404 is sufficient to allow the catheter 402 tobend within the nasal cavity 104 to align the spray orifice 406 with thesphenopalatine/pterygopalatine recess 118. In one embodiment theintrinsic curvature 404 may bend between about 45° and about 90° toallow the catheter 402 to be placed within thesphenopalatine/pterygopalatine recess 118 without hitting the inferiorsurface 304 of the nasal bone 122 of the patient.

FIG. 5C illustrates another embodiment of the catheter 402 portion ofthe sphenocath 400 with a rigid member 501 which surrounds the catheter402. In this embodiment, the rigid member 501 is a sleeve 504surrounding the catheter 402. In certain embodiments the sleeve 504 issufficiently rigid to straighten the intrinsic curvature 404 when thecatheter 402 is received within the sleeve 504. One of skill in the artwill recognize that in certain embodiments, such as where a sleeve 504is used in place of a stylus 410, the sphenocath 400 may include asingle lumen catheter 402 rather than the multiple lumen catheter 402illustrated in FIGS. 5A-5D. As discussed below with reference to FIGS.6A-6C, in other embodiments, the catheter 402 may be configured with asmany additional lumens as may be required for additional complexprocedures such as fiber optics for visually guiding the catheter intothe sphenopalatine/pterygopalatine recess 118 or vacuum tubes configuredto aspirate substances from within the sphenopalatine/pterygopalatinerecess 118.

FIG. 5D illustrates an embodiment of the catheter 402 portion of thesphenocath 400 with the sleeve 504 partially withdrawn from the catheter402 to expose the intrinsic curvature 404 of the catheter 402. As thesleeve 504 is removed from catheter 402 in the direction of arrow 506the intrinsic curvature 404 of the catheter is no longer straightened bythe sleeve 504. Therefore, the catheter 402 bends at the intrinsiccurvature 404. Thus, once the sphenocath 400, including the sleeve 504,has been inserted deep enough into the patient's nasal cavity 104 suchthat the spray orifice 406 has passed the middle sinus turbinate 114,the sleeve 504 is withdrawn from catheter 402 to allow the catheter tobend at the intrinsic curvature 404. The sphenocath 400 may then beinserted all the way into the sphenopalatine/pterygopalatine recess 118to deliver the anesthetic or medication to thesphenopalatine/pterygopalatine ganglia 120 or surrounding anatomicalstructure.

FIG. 6A through FIG. 6C illustrate various embodiments of a crosssection of the catheter 402 of the sphenocath 400. In certainembodiments, such as the embodiment illustrated in FIG. 6A one of thelumens may be keyed to receive the stylus 410 in only one direction suchas lumen 602. By keying lumen 602 to receive the stylus 410 in only oneconfiguration, the pull tab of the stylus 410, such as pull tab 502 ofFIGS. 5A and 5B, may be configured to indicate the rotational directionof the spray orifice 406. Further, by keying one of the lumens toreceive the stylus 410 in only one direction the entire sphenocath 400may be rotated by the pull tab 502. Thus, in certain embodiments therotational direction indicator 418 and a rotation tab 420 may be omittedwhere one of the lumens is keyed to receive the stylus 410 in only onedirection. While the catheter 402 illustrated in FIG. 6 a comprises around structure with two lumens 602 and 604, one skilled in the art willrecognize the catheter 402 structure may comprise any number of shapessuch as the shapes illustrated in FIGS. 6B and 6C. One skilled in theart will recognize that the shape illustrated in FIG. 6A through FIG. 6Care for illustrative purposes only and are in no way limiting of theshapes which may comprise the catheter 402 and lumens 602, 604, 606,608, 610, 612, 614, 616, 618 and 620.

In certain embodiments an additional orientation identifier 622 may bedisposed on the top surface of the catheter 402. In one embodiment theorientation identifier 622 serves as an additional visual cue to assiststhe physician in determining the rotational orientation of thesphenocath 400 so that the physician will know which direction theintrinsic curvature 404 will bend when the stylus 410 is removed.

In the embodiments illustrated in FIG. 6A the catheter 402 comprises twolumens 602 and 604. In the embodiment illustrated in FIG. 6B thecatheter 402 comprises three lumens 606, 608 and 610 and in theembodiment illustrated in FIG. 6C the catheter 402 comprises four lumens612, 614, 618 and 620. One skilled in the art will recognize that thecatheter 402 may be configured with as many additional lumens as may berequired for additional complex procedures such as fiber optics forvisually guiding the catheter into the sphenopalatine/pterygopalatinerecess 118 or vacuum tubes configured to aspirate substances from withinthe sphenopalatine/pterygopalatine recess 118.

FIG. 7 illustrates one embodiment of the present invention wherein thesphenocath 400 is inserted through the nostril 202 into the nasal canal104 and past the anterior ridge 302 of the middle sinus turbinate 114.To maintain a straight sphenocath 400 the stylus 410 is fully insertedinto lumen 401 (note that either lumen 401 or 403 may be configured toreceive the stylus 410). Depth indicator 408 is configured to signal thephysician when the spray orifice 406 of the sphenocath 400 issufficiently deep enough within the patient's nasal cavity 104 to clearthe anterior ridge 302 of the middle sinus turbinate 114.

FIG. 8 illustrates one embodiment of the present invention wherein sprayorifice 406 of the sphenocath 400 has passed the middle sinus turbinate114 and the stylus 410 has been partially withdrawn from within lumen401. As the stylus is withdrawn from lumen 401 the catheter 402 bendsdue to intrinsic curvature 404 of the catheter 402. The sphenocath 400can then be further inserted into the nasal cavity 104 deeper within thesphenopalatine/pterygopalatine recess 118. In certain embodiments asecond depth indicator 802 may be disposed on the sphenocath 400 toidentify the correct depth for administering the anesthetic ormedication to the sphenopalatine/pterygopalatine ganglia 120 orsurrounding anatomical structure. Once the sphenocath 400 is inserted tothe correct depth the syringe 416 or other dispensing means delivers adesired amount of medication or anesthetic into the medication deliveryport 414, through the lumen 403 to be dispersed at the spray orifice 406to the sphenopalatine/pterygopalatine ganglia 120. Because the patientis in a supine position the medication or anesthetic pools in thesphenopalatine/pterygopalatine recess 118.

The schematic flow chart diagram that follows is generally set forth asa logical flow chart diagram. As such, the depicted order and labeledsteps are indicative of one embodiment of the presented method. Othersteps and methods may be conceived that are equivalent in function,logic, or effect to one or more steps, or portions thereof, of theillustrated method. Additionally, the format and symbols employed areprovided to explain the logical steps of the method and are understoodnot to limit the scope of the method. Although various arrow types andline types may be employed in the flow chart diagrams, they areunderstood not to limit the scope of the corresponding method. Somearrows or other connectors may be used to indicate only the logical flowof the method. For instance, an arrow may indicate a waiting ormonitoring period of unspecified duration between enumerated steps ofthe depicted method. Additionally, the order in which a particularmethod occurs may or may not strictly adhere to the order of thecorresponding steps shown.

FIG. 9 illustrates another embodiment of a sphenocath 900 having acatheter 902 portion which includes an intrinsic curvature 904 near aninsertion end 906 and a rotation tab 908 near a manipulation end 910. Incertain embodiments the sphenocath 900 also includes a medicationdelivery port 912 located near the manipulation end 910 and a sprayorifice 914 located at the insertion end 906.

In the embodiment illustrated in FIG. 9, the medication delivery port912 includes a Luer fitting 916 keyed to fit a syringe (not shown). Themedication delivery port 912 is fluidly connected to the catheter 902portion through a stylet tube 918. In certain embodiments the stylettube 918 is sufficiently rigid to straighten the intrinsic curvature 904in the insertion end 906 of the catheter 902 when the stylet tube 918 isinserted into the catheter 902 in the direction of arrow 920. As thestylet tube 918 is withdrawn from the catheter 902 in a directionopposite arrow 920, past a point where the stylet tube 918 support theintrinsic curvature 904, the catheter 902 bends due to the intrinsiccurvature 904. For example, once the stylet tube 918 is withdrawn fromthe catheter 902 past a certain point (such as point 922) the catheter902 bends in the direction shown due to the intrinsic curvature 904. Incertain embodiments the catheter 902 may begin to bend immediately asthe stylet tube 918 is withdrawn from the catheter 902. In otherembodiments catheter 902 only bends once the stylet tube 918 has beenremoved past a point 922 where the intrinsic curvature 904 begins.

In certain embodiments the manipulation end 910 of the spenocath 900includes a rotation tab 908 for directing the spray orifice 914 in thedirection of the sphenopalatine/pterygopalatine recess 118 when thespray orifice 914 has passed the middle sinus turbinate 114. Therotation tab 908 may be aligned with the intrinsic curvature 904 in apredefined orientation to signal to the physician the direction of thespray orifice 916 when the sphenocath 900 is disposed within a patient'snasal cavity 104. As discussed above, the sphenocath 900 may includedepth indicators 924 to signal a proper depth within the nasal cavity104 to insert the sphenocath 900 into sphenopalatine/pterygopalatinerecess 118.

FIG. 10 is a schematic flow chart diagram illustrating one embodiment ofa method 1000 for treating sympathetic mediated cephalgia (headaches.)In one embodiment the method starts 1002 and the patient is placed in asupine position. In certain embodiments, the patient may already be inthe supine position. In other embodiments, the physician may wish toadminister the treatment with the patient in a standing or seatedposition and thus, this step may be omitted.

The physician inserts 1006 a stylus, such as stylus 410 into a lumenwithin a sphenocath such as the sphenocath 400 of FIG. 4. The stylus 410may act to straighten the sphenocath 400 to allow for easy insertioninto a patients nasal cavity 104. In certain embodiments the stylus 410may already be inserted within the lumen and thus this step may beomitted.

The sphenocath 400 is inserted 1008 into the patient's nostril 202 andadvanced through the nasal cavity 104 to a position wherein the sprayorifice 406 of the sphenocath 400 has passed the middle sinus turbinate114. The stylus 410 is withdrawn 1010 from the sphenocath 400 such thatthe sphenocath 400 curves due to an intrinsic curvature 404 of thecatheter 402. The sphenocath 400 is advanced 1012 into thesphenopalatine/pterygopalatine recess 118. Anesthetic is dispensed 1014into the sphenopalatine/pterygopalatine recess 118.

The anesthetic may cause a temporary loss of sensation in the nasalcavity and may, in certain instances, drain into the patients throatcausing a loss of sensation in the patients throat. Therefore, incertain embodiments the physician may monitor 1016 the patient in thesupine position for a period of time to make sure that the patient doesnot have any adverse reactions to the anesthetics. In one embodiment thepatient may be observed 1018 to determine the efficacy of the procedureand the method ends 1020.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

1. An apparatus facilitating intranasal administration of a medicationto a patients sphenopalatine/pterygopalatine recess, the apparatuscomprising: a catheter having a lumen disposed therethrough, thecatheter comprising an insertion end and a manipulation end, theinsertion end having an intrinsic curvature with respect to alongitudinal axis of the catheter such that the insertion end of thecatheter lies in a first plane and the manipulation end lies in a secondplane, wherein the catheter smoothly transitions between the first planeand the second plane, the intrinsic curvature conforming to a patientsnasal anatomy such that the catheter may be inserted into asphenopalatine/pterygopalatine recess; a straightening member configuredto removably engage the catheter, wherein the straightening memberstraightens the intrinsic curvature of the insertion end such that thefirst plane and the second plane are aligned when the catheter isengaged by the straightening member;
 2. The apparatus of claim 1,wherein the catheter further comprising a second lumen, wherein thestraightening member comprises a stylus configured to be received withinthe second lumen.
 3. The apparatus of claim 2, wherein the stylus iskeyed to fit within the second lumen in one predefined orientation, thestylus identifying a direction of the intrinsic curvature when thestylus is disposed within the second lumen.
 4. The apparatus of claim 1,further comprising a spray orifice and a medication delivery port, thespray orifice disposed adjacent to the insertion end of the catheter,the spray orifice in fluid communication with the lumen, the medicationdelivery port configured to receive a medication and deliver themedication through the lumen to the spray orifice.
 5. The apparatus ofclaim 1, wherein the straightening member comprises a sleeve configuredto receive the catheter, wherein the sleeve straightens the intrinsiccurvature of the catheter when the catheter is received within thesleeve.
 6. The apparatus of claim 1, further comprising a rotationaldirection indicator disposed on the catheter, the rotational directionindicator identifying a direction of the intrinsic curvature.
 7. Theapparatus of claim 1, further comprising a depth indicator disposed onthe catheter, the depth indicator identifying a defined depth.
 8. Theapparatus of claim 7, wherein the defined depth comprises a depthequaling a distance between an entrance to a patient'ssphenopalatine/pterygopalatine recess and an external entrance to thepatient's nostril.
 9. The apparatus of claim 7, further comprising asecond depth indicator disposed on the catheter, the second depthindicator identifying a second defined depth, the second defined depthcomprising a depth equaling a distance between a location at a posteriorposition within a patient's sphenopalatine/pterygopalatine recess and anexternal entrance to the patient's nostril.
 10. The apparatus of claim7, wherein the depth indicator is moveable on the catheter such that aphysician can adjust a position of the depth indicator according to apatient's nasal anatomy.
 11. The apparatus of claim 7, wherein the depthindicator identifies the typical distance between a patient's externalopening of a nostril and the patient's sphenopalatine/pterygopalatinerecess according to a criteria selected from a patient's gender and age.12. An apparatus facilitating intranasal administration of a medicationto a patients sphenopalatine/pterygopalatine recess, the apparatuscomprising: a catheter having a first lumen and a second lumen, thecatheter comprising an insertion end and a manipulation end, theinsertion end having an intrinsic curvature with respect to alongitudinal axis of the catheter such that the insertion end of thecatheter lies in a first plane and the manipulation end lies in a secondplane, wherein the catheter smoothly transitions between the first planeand the second plane, the intrinsic curvature conforming to a patientsnasal anatomy such that the catheter may be inserted into asphenopalatine/pterygopalatine recess; a stylus configured to beremovably received within one of the first lumen and the second lumen,wherein the stylus straightens the intrinsic curvature of the insertionend such that the first plane and the second plane are aligned when thestylus is received within one of the first lumen and the second lumen; aspray orifice disposed adjacent to the insertion end of the catheter,the spray orifice in fluid communication with at least one of the firstlumen and the second lumen; and a medication delivery port disposedadjacent to the manipulation end of the catheter, the medicationdelivery port configured to receive a medication and deliver amedication through at least one of the first lumen and the second lumento the spray orifice.
 13. The apparatus of claim 12, wherein the stylusis keyed to fit within at least one of the first lumen and the secondlumen in one predefined orientation, the stylus identifying a directionof the intrinsic curvature when the stylus is disposed within one of thefirst lumen and the second lumen.
 14. The apparatus of claim 12, furthercomprising a rotational direction indicator disposed on the catheter,the rotational direction indicator identifying a direction of theintrinsic curvature.
 15. The apparatus of claim 1, further comprising adepth indicator disposed on the catheter, the depth indicatoridentifying a defined depth, wherein the defined depth comprises a depthequaling a distance between an entrance to a patient'ssphenopalatine/pterygopalatine recess and an external entrance to thepatient's nostril.
 16. The apparatus of claim 15, further comprising asecond depth indicator disposed on the catheter, the second depthindicator identifying a second defined depth, the second defined depthcomprising a depth equaling a distance between a location at a posteriorposition within a patient's sphenopalatine/pterygopalatine recess and anexternal entrance to the patient's nostril.
 17. The apparatus of claim15, wherein the depth indicator is moveable on the catheter such that aphysician can adjust a position of the depth indicator according to apatient's nasal anatomy.
 18. A method for treating migraines, the methodcomprising: inserting a catheter and a straightening member into anostril of a patient, the catheter comprising an insertion end and amanipulation end, the insertion end having an intrinsic curvature withrespect to a longitudinal axis of the catheter such that the insertionend of the catheter lies in a first plane and the manipulation end liesin a second plane, wherein the catheter smoothly transitions between thefirst plane and the second plane, the intrinsic curvature conforming toa patients nasal anatomy such that the catheter may be inserted into asphenopalatine/pterygopalatine recess, the straightening memberremovably engaging the catheter, wherein the straightening memberstraightens the intrinsic curvature of the insertion end such that thefirst plane and the second plane are aligned when the catheter isengaged by the straightening member; advancing the catheter and thestraightening member past a middle sinus turbinate in the nostril of thepatient; removing the straightening member from the catheter such thatthe catheter bends in a direction towards asphenopalatine/pterygopalatine recess of the patient; advancing thecatheter into the sphenopalatine/pterygopalatine recess; and dispensinga medication to a sphenopalatine/pterygopalatine ganglia disposed withinthe sphenopalatine/pterygopalatine recess of the patient.
 19. The methodof claim 18, further comprising identifying a direction of the intrinsiccurvature and aligning the intrinsic curvature of the catheter with thepatient's sphenopalatine/pterygopalatine recess.
 20. The method of claim18, further comprising identifying a defined depth of the catheter, thedefined depth comprising a depth equaling a distance between an entranceto a patient's sphenopalatine/pterygopalatine recess and an externalentrance to the patient's nostril.